[Ip-health] Roche seeks compulsory license for Amgen patent, in US

[James Love]

While the Swiss government bashes Thailand for issuing compulsory
licenses on cancer drug patents, the Swiss firm Roche is asking a Los
Angles court for a compulsory license on three Amgen patents.

http://www.reuters.com/article/marketsNews/idUSN2642636620080326

U.S. judge seeks expert advice on Amgen-Roche case
Wed Mar 26, 2008 6:10pm EDT

(Adds Amgen comment, paragraphs 10-12)

By Deena Beasley

LOS ANGELES, March 26 (Reuters) - The federal judge overseeing Amgen
Inc's (AMGN.O: Quote, Profile, Research) patent infringement case
against Roche Holding AG (ROG.VX: Quote, Profile, Research) ordered an
expert be appointed to recommend how to compare the dosing and prices of
the companies' anemia drugs.

The Wednesday order delays until at least mid-June the judge's decision
on whether or not to bar U.S. sales of Roche's Mircera, a court
spokeswoman said.

A U.S. District Court jury in Boston found in October that patents on
Amgen's anemia drugs were valid and that Mircera, which is approved for
treatment of anemia in kidney disease patients, infringed three of them.

But U.S. District Judge William Young has declined to issue a permanent
injunction barring sales of Mircera in the United States and has said he
may instead impose a licensing deal allowing Roche to launch its drug --
which is administered less frequently than Amgen's Epogen and Aranesp --
if certain terms were met.

Although Amgen prevailed in the patent case, a compulsory license is a
possibility following a 2006 U.S. Supreme Court decision in eBay vs.
MercExchange that weakened the powers of courts to issue injunctions
barring firms from using infringing technology.

Judge Young has said it may not be in the public interest to ban Mircera
sales and Roche agreed last week to his suggested conditions for a
license, including the payment of a 22.5 percent royalty to Amgen and a
Medicare sales price below that of Epogen.

In the order, Young said he "continues to grapple with complex issues
related to Amgen's request" for a permanent injunction and ordered the
appointment of a "special master" to make recommended findings regarding
price parity, as well as the dose conversion ratios for Mircera and
Epogen.

The judge's action "indicates he is considering a Mircera launch despite
Amgen's arguments regarding the damage that not issuing a permanent
injunction can cause to the U.S. patent system," Citigroup analyst Yaron
Werber said in a research note.

Judge Young gave Amgen and Roche 15 days to submit a list of candidates
and said the expert will have 60 days after that to make the requested
findings.

Separately, Amgen filed a motion with the court asking the judge to
allow for a trial to determine the full amount of compensation due Amgen
if Roche is allowed to commercialize its drug in the United States.

Amgen said in a statement that it continues to believe a permanent
injunction is the appropriate remedy in the case and said it would
withdraw the motion if a permanent injunction is granted.

"The royalty payments and other remedies recently discussed in court
would not begin to fully compensate for Amgen's lost profits," the
company said.

Bear Stearns analyst Mark Schoenebaum said in a conference call he
expected Amgen's combined sales of Epogen and Aranesp for kidney disease
to total $2.9 billion next year.

He estimated that for every $100 million in sales that could be lost to
Roche, Amgen's annual earnings would drop by a net 5 cents per share.

Shares of Amgen, which hit a 12 month low last week amid renewed
concerns about the safety of anemia drugs for cancer patients, rose
$1.16, or 2.84 percent, to close at $42 on Nasdaq. (Reporting by Deena
Beasley; Editing by Carol Bishopric and Leslie Gevirtz)


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_____________________________
James Love, Knowledge Ecology International (KEI)
http://www.keionline.org, mailto:james.love@keionline.org
voice +1.202.332.2670, fax +1.202.332.2673, US mobile +1.202.361.3040,
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